Balloon protection and rewrapping devices and related methods of use

ABSTRACT

A movable protection and/or rewrapping device for a balloon catheter may include a tubular member with a bore extending along a length thereof. The tubular member may have at least one rib disposed on an inner surface of the bore. The tubular member may be flared away from the bore at one end and inwardly tapered at the other end. The rewrapping device may include an actuator configured to open a longitudinal slit in the tubular member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. §119 to U.S.Provisional Application Ser. No. 61/935,696, filed Feb. 4, 2014, theentirety of which is incorporated herein by reference.

FIELD

Embodiments of the present disclosure are broadly directed to ballooncatheters. In particular, the disclosure relates to devices, systems andmethods for protecting and/or wrapping or rewrapping balloon catheters.

BACKGROUND

Certain treatments require temporary or permanent interruption ormodification of select nerve function. One example treatment is renalnerve ablation, which is sometimes used to treat conditions related tocongestive heart failure. Some of the known renal denervation systemsuse a catheter shaft having a balloon coupled to its distal end forablation. Renal denervation procedures involve contra-lateralapplication of therapy targeting both right and left renal artery. Insome scenarios, same balloon may be used to provide treatment to boththe right and left renal artery.

Typically balloons usually have flex circuits with one or more pairs ofelectrodes and temperature sensors disposed on the balloon, to deliverRF energy to a target nerve. Once unwrapped and used it becomesdifficult to rewrap the balloon to its original profile for re-use at anew treatment site. Also, the balloon does not have enough columnstrength to reinsert the balloon through a hemostasis valve withoutdamaging the balloon.

Drug coated balloons are packaged with a protection device over theballoon, however the protection device must be removed prior to loadingthe balloon catheter onto a guide wire or into a guide catheter.Handling the balloon may result in disruption of the drug coating.Additionally, the balloon may not have enough column strength to insertthe balloon through a hemostasis valve without damaging the balloon anddisrupting the drug coating.

Hence, there exists a need of for a device to protect a balloon duringuse and to aid insertion and/or rewrapping and re-insertion of theballoon through a hemostasis valve.

SUMMARY

In one embodiment, the present disclosure may include a removableprotection device for a balloon catheter. The removable protectiondevice may include a tubular member, and at least one rib. The tubularmember may include a bore extending along a length thereof. The tubularmember may be flared away from the bore at one end. The rib may extendalong an inner surface of the bore.

In another embodiment, the present disclosure may include a laterallyremovable protection and/or rewrapping device for a balloon catheter.The lateral removable protection and/or rewrapping device may include atubular member and an actuator. The tubular member may have a first end,a second end, and a bore that may extend between the first end and thesecond end. The tubular member may also include a slit extending fromthe first end to the second end. The tubular member may further includea hinge region opposite the slit. The bore may have a shaped innersurface that may be configured to rewrap a deflated balloon with two ormore folds. The actuator may be configured to expand the slit therebyallowing the tubular member to be inserted laterally over a cathetershaft.

In another embodiment, the present disclosure may include a method ofinserting a balloon through a hemostasis valve. The method includesproviding a catheter shaft having a proximal end and a distal end, andan expandable balloon disposed on the distal end, the balloon being in adeflated configuration, moving a protection device onto the balloon, theprotection device including a tubular member having a first end, asecond end, a bore extending therebetween, and an inward taper at thesecond end, guiding the distal end of the catheter shaft and ballooninto the hemostasis valve by inserting the tapered second end of theprotection device at least partially into the hemostasis valve, andremoving the protection device from the hemostasis valve.

In another embodiment, the present disclosure may include a method ofrewrapping a deflated balloon. The method includes providing a cathetershaft having a proximal end and a distal end and an expandable balloondisposed on the distal end. The method may also include expanding theballoon and then deflating the balloon. The method may further includeproviding a rewrapping device and moving the rewrapping device distallyover the catheter shaft and onto the balloon thereby rewrapping theballoon. The rewrapping device may include a tubular member having abore that may extend along a length thereof, and at least one ribextending along an inner surface of the bore.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present disclosure.The figures, and detailed description, which follow, more particularlyexemplify these embodiments, but are also intended as exemplary and notlimiting.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a removable protection and rewrappingdevice, in accordance with an aspect of the present invention;

FIG. 2 is a perspective view of the removable protection and rewrappingdevice of FIG. 1 taken from a flared end;

FIG. 3 is a side view of the removable protection and rewrapping deviceof FIG. 1;

FIG. 4 is a perspective view of another removable protection andrewrapping device, in accordance with the present disclosure;

FIG. 5 is a view of the removable protection and rewrapping device ofFIG. 4 taken from a flared end;

FIG. 6 is a side view of a removable protection and rewrapping device,in accordance with another aspect of the present disclosure;

FIG. 7 is a perspective view of the removable protection and rewrappingdevice of FIG. 6, in accordance with an aspect of the presentdisclosure;

FIG. 8 is a front view of the removable protection and rewrapping deviceof FIG. 7 taken from the flared end;

FIG. 9 is a perspective view of a removable protection and rewrappingdevice, in accordance with another aspect of the present disclosure;

FIG. 10 is a front view of the removable protection and rewrappingdevice of FIG. 9 taken from the flared end;

FIG. 11 is perspective view of a removable protection and rewrappingdevice, in accordance with yet another aspect of the present disclosure;

FIG. 12 is front view of the removable protection and rewrapping deviceof FIG. 11 from the flared end; and

FIGS. 13A and 13B are elevational views illustrating inserting a ballooncatheter into a hemostasis valve with one example of a protectiondevice.

While embodiments of the present disclosure are amenable to variousmodifications and alternative forms, specifics thereof have been shownby way of example in the drawings and will be described in detail. Itshould be understood, however, that the intention is not to limitaspects of the disclosure to the particular embodiments described. Onthe contrary, the intention is to cover all modifications, equivalents,and alternatives falling within the spirit and scope of the presentdisclosure.

DETAILED DESCRIPTION

Renal denervation procedures usually involve bilateral or contralateraltreatment. In such scenarios, a catheter shaft may be used to performthe procedure. The catheter shaft may have a proximal end, distal endand may further include a balloon disposed at the distal end of thecatheter shaft.

An introduction sheath may be deployed through an entry point within afirst body lumen (e.g., right renal artery) to guide the catheter shaftto a treatment site. A hemostasis valve may be coupled to theintroduction sheath to prevent blood leak and/or accidental fluid flowfrom the entry point. The catheter shaft may be advanced into theintroduction sheath through the hemostasis valve to the treatmentlocation where the balloon may be inflated. Once the procedure isperformed, the balloon may be deflated and the catheter shaft may beretracted from the introduction sheath. Then, the introduction sheathmay be deployed within a second body lumen (e.g., left renal artery) toperform a similar procedure. The catheter shaft used for treating thefirst body lumen needs to be reinserted into the introduction sheaththrough the hemostasis valve, and this may require the deflated balloonto be wrapped to a profile that can be easily passed through thehemostasis valve without damaging the balloon.

In some treatment procedures, two different sized balloons may berequired, for example, a 7 mm balloon may be used to treat a main arteryand then a 3 mm or 4 mm balloon may be used to treat the accessoryartery. After treating one side, the 7 mm balloon is then used to treatthe second side main artery, followed again by the 3 mm or 4 mm balloonfor the second accessory artery. If the balloons cannot be successfullyrefolded, new balloons may be needed for the second part of theprocedure.

In other treatment procedures, balloons having a surface coatingincluding active pharmaceutical ingredients (APIs) and excipients mayrequire handling by the user during loading of the balloon catheter intoa guide catheter or onto a guide wire. The drug coated balloon isgenerally packaged with a protection device over the coated balloon,however this protection device is removed before the drug coated ballooncan be loaded onto a guide wire. The drug coating may be disrupted whenthe drug coated balloon is handled by the user.

In view of the above situations and concerns, the present disclosureprovides balloon protection and/or rewrapping devices to protect and/orrewrap the deflated balloon such that the balloon can be rewrapped withsuitable folds without being damaged. Also, the device may assist inprotection of the balloon during insertion through the hemostasis valve.The protection/rewrapping device may also protect the user from contactwith an API including substances with potentially adverse side effects,such as paclitaxel. The protection/rewrapping device may be removed oncethe balloon is advanced.

FIG. 1 is a perspective view of a laterally removableprotection/rewrapping device 100. In some embodiments, the laterallyremovable device 100 may be disposed laterally over a drug coatedballoon to provide protection to the balloon and to provide a means ofhandling the balloon without disrupting the drug coating. In otherembodiments, the device 100 may be disposed laterally over a catheter ata location proximal to a deflated balloon and then the device 100 may beadvanced over the deflated balloon to aid in rewrapping the deflatedballoon.

The laterally removable protection/rewrapping device 100 may include atubular member 102 having a first end 104 and a second end 106. One endof the tubular member 102 may be flared outwardly. In some examples, theflared end 105 of the tubular member 102 may allow movement of theballoon through the tubular member 102 preventing any accidental damageto the balloon or the catheter shaft. In some examples, one end of thetubular member 102 may have an inward taper 103. The taper 103 may aidin inserting the balloon catheter into a hemostasis valve. The taper 103may be configured to be partially inserted into the valve, such that thedevice 100 may be used to grasp and handle the balloon and insert itinto the valve, providing protection to the balloon and any coating onthe balloon.

The tubular member 102 may define a bore 108 such that the bore 108 maybe a tube-like channel extending along a longitudinal length of thetubular member 102. The bore 108 may receive the catheter shaft and/ordeflated balloon (not shown).

The bore 108 may include a shaped inner surface configured to rewrap adeflated balloon with two or more folds. In some embodiments, thetubular member 102 may be suitably dimensioned to receive the cathetershaft such that an inner diameter of the tubular member 102 may bealmost equal to a profile of the catheter shaft. In other embodiments,the tubular member 102 may have the inner diameter relatively smallerthan that of the profile of catheter shaft such that the catheter shaftand/or the balloon may be compressed within the bore 108 of the tubularmember 102 thereby engaging and securing the catheter shaft and/or theballoon within the tubular member 102 before insertion.

As shown in FIG. 2, the bore 108 of the tubular member 102 may have across-section that is substantially circular. It is contemplated thatthe bore 108 may also have an ovoid cross-section. In some embodiments,the bore 108 may possess a triangular cross-section with three arcuatesurfaces that may fold the balloon forming a three wing fold. In someembodiments, the bore 108 may be a substantially X-shaped cross-sectionsuch that the balloon may be folded with four wings. In otherembodiments, the bore 108 may have a star shaped cross-section such thatthe balloon disposed within the bore 108 may be folded forming fivewings.

The inner surface of the tubular member 102 defined by the bore 108 mayinclude a coating (not shown) of lubricious material in order to allowsmooth passage of the balloon and/or the catheter shaft. Examples ofsuch materials may include polymers such as, but not limited to, PTFE,FEP, or the like.

The tubular member 102 may further include a slit 110 defined along thelongitudinal length of the tubular member 102. The slit 110 may enablethe tubular member 102 to receive the catheter shaft laterally (i.e., byside-loading) by transitioning the tubular member 102 between an openand a closed configuration. To enable the tubular member 102 transitionbetween the open and the closed configuration, the tubular member 102may include a hinge region 112 formed opposite the slit 110. Thelaterally removable rewrapping device may also include an actuator 114proximate the hinge region 112 configured to expand the slit 110,thereby opening the tubular member 102. The hinge region 112 may includea scored line, partial cut, or thinned region extending longitudinallyalong the tubular member 102 opposite the slit 110. The actuator 114 mayinclude a first tab 116 and a second tab 118 arranged such that when theuser moves the first tab 116 and the second tab 118 towards each other,the slit 110 expands, thereby opening the tubular member 102. The firsttab 116 and the second tab 118 may be spaced apart and extend radiallyaway from the tubular member 102, as shown in FIG. 2.

The first tab 116 and the second tab 118 may have a circular structureto provide a surface for the user's fingers to grasp the tabs 116, 118easily. To facilitate a firm grip, the first tab 116 and the second tab118 may have a pattern formed on an outer surface of the first tab 116and the second 118. The pattern may include grooves, lines,micro-protrusions, or the like. In some embodiments, the first tab 116and the second tab 118 may have shape such as rectangular, square, oval,or the like with smooth edges to prevent any accidental damage to theuser. The first tab 116 and the second tab 118 may be made of anysuitable material, for example, a plastic or polymer, such as, silicone,polyvinylchloride, polyurethane, or the like; a metal or alloy, such astitanium or titanium alloys, nickel, aluminum, stainless steel, copper,gold, silver, platinum or alloys thereof, or any other suitable materialor combination of materials. In at least some embodiments, the first tab116 and the second tab 118 may be made of the same material as that ofthe tubular member 102. In at least some embodiments, the first tab 116and the second tab 118 and the tubular member 102 may be made ofdifferent materials.

The actuator 114 can be integrally, e.g., monolithically formed with thetubular member 102. Alternatively, the actuator 114 can be formedseparately and coupled to the tubular member 102 using a suitabletechnique. For example, techniques such as welding, soldering, or thelike; adhesives such as poly(glycerol-co-sebacate acrylate), or thelike; fasteners such as a pin, screw, or the like, or any other suitablemethods or materials can be used to attach the actuator 114 to thetubular member 102. The techniques used to form the tubular member 102may include injection molding, extrusion or the like.

Additionally, in some embodiments, one or more tensioning elements (notshown) may be employed to bias the tubular member 102 in the closedposition. The tensioning element may be capable of being elongated, andmay be biased to return to its original shape when the tension isreleased. Examples of such tensioning elements may include a spring,tension bands, or the like. The tensioning element may be formed usingmaterials that are elastic, flexible, and strong such that thetensioning element does not break upon actuation. Examples of suchmaterials may include, but are not limited to, polymers such as rubber,silicone or the like; copolymers such as ABA triblock, or the like, orany other suitable elastomeric biocompatible material that is well knownin the art. In some embodiments, the tensioning element, in the form ofa spring, may be made using materials such as stainless steel, titanium,titanium alloys, or any other suitable material.

The tensioning element may bias the actuator 114 to keep the tubularmember 102 closed, thereby gripping portions of the catheter shaftand/or the balloon in the bore 108 by preventing the tubular member 102from spontaneously opening when in the closed position. Hence,accidental disengagement of the catheter shaft and/or balloon from thetubular member 102 may be prevented.

In some embodiments, the laterally removable device 100 can be used as aballoon protector such as for drug coated balloons. The laterallyremovable device 100 can be applied onto and removed laterally from thedrug eluting balloon. As the drug coated balloons may have a coating ofa drug disposed on the outer surface, the laterally removable device 100may enable the physician to insert the balloon through the hemostasisvalve without directly contacting the balloon. Hence, this may protectthe drug coating on the balloon from being hydrolyzed or disruptedduring contact with the user.

In such scenarios, the tubular member 102 can be formed using a materialto reduce stress/strain applied to the balloon. One example of such amaterial is a transparent thermoplastic polyamide based on aliphatic andcycloaliphatic blocks, such as Grilamid® TR-55-LX (EMS-Grivory,Switzerland). Also, as the drug coated balloon may come in contact withthe inner surface of the tubular member 102, the bore 108 may be formedusing lubricious material. In some embodiments, the bore 108 may includea coating of the lubricious material that will not cause damage to thedrug coated balloon. The ability of the tubular member 102 to openlongitudinally may minimize placement error as well as allow theoperator a holding position during placement of the balloon through thehemostasis valve.

FIG. 2 shows a view of the device 100 of FIG. 1 from the flared end 105.In the illustrated embodiment, the device 100 is in a closed state. Asshown, the tubular member 102 may include the actuator 114 disposedproximate the hinge region 112. The actuator 114 may include the firsttab 116 and the second tab 118 disposed at an acute angle such that themovement of the first tab 116 and the second tab 118 towards each otherexpands the slit 110 thereby opening the tubular member 102. The devicecan then be deployed laterally about the catheter shaft.

As shown in FIG. 3, the flared end 105 may include an outward taperingsuch that an outer diameter of the tubular member 102 increases towardsthe first end 104. In some embodiments, the flared end 105 may minimizethe damage to the balloon while inserting the balloon through thehemostasis valve. In some embodiments, the device 100 may be advancedproximally over the balloon and the flared end 105 may aid in insertionof the balloon within the device 100 and facilitate folding of theballoon.

FIG. 3 shows a side of the device 100 of FIG. 1. In this figure, thedevice 100 is shown to include a tubular member 102 with a flared end105 and a tapered end 103 aiding insertion of the balloon through thehemostasis valve. The laterally removable device 100 may be disposedwith the tapered end 103 disposed distally such that when advanced overthe deflated balloon, the device 100 may be used to insert the deflatedballoon into a hemostasis valve.

FIG. 4 is a perspective view of a laterally removableprotection/rewrapping device 400 with one or more ribs 420 defined alongan inner surface of a bore 408 of tubular member 402. The ribs 420 maybe protrusions extending along the longitudinal length of the tubularmember 402. The tubular member 402 can be a tube extruded with integralribs 420 and with a uniform outer diameter. The inner diameter betweenthe ribs 420 may be substantially uniform. In some examples, the ribs420 may extend into a tapered end 403 of reduced diameter, as shown inFIG. 4. In other examples, the ribs 420 may extend only along theportion of the tubular member 402 having a uniform diameter.

As shown in FIG. 5, the tubular member 402 includes three ribs 420 thatare spaced apart around the inner surface of the bore 408. In someembodiments, the ribs 420 may be uniformly spaced. In other embodiments,the ribs may be disposed in any pattern. The tubular member 402 mayinclude one, two, three, four, five, six, or more ribs 420, dependingupon various factors such as the desired folding pattern, the shape andsize of the balloon and the number and location of electrodes on theballoon. The ribs 420 may be arranged in different configurations. Insome embodiments, the ribs 420 may extend substantially straight alongthe entire longitudinal length of the tubular member 402. In otherembodiments, the ribs 420 may extend along part of the length of thetubular member 402. In other embodiments (not shown), the ribs 420 mayextend helically along the longitudinal length of the tubular member402.

Referring back to the FIG. 4, additionally, similarly to the embodimentof FIG. 1, the laterally removable protection/rewrapping device 400 mayinclude an actuator 414 including a first tab 416 and a second tab 418disposed opposite to a slit 410. The actuator 414 may enable totransition the tubular member 402 between an open and a closedconfigurations. Once in an open state, the tubular member 402 may beadvanced laterally over a deflated balloon such as a drug coatedballoon. In other examples, the tubular member 402 may be advancedlaterally over a catheter shaft proximal of a balloon and then may beadvanced over the deflated balloon by pulling the catheter shaftproximally through the device 400 or pushing the device 400 distallyover the catheter and onto the balloon. In other examples, the device400 may be laterally attached to the catheter shaft distal of a balloonand the device may then be advanced proximally over the balloon. In thisexample, the flared end 405 may protect and guide the balloon into thedevice 400. As the balloon (not shown) is inserted into the bore 408 ofthe device 400, the ribs 420 may form valleys in the balloon, therebyaiding balloon folding. Additionally, the catheter shaft may be twistedor rotated as the balloon is received with the device 400 to further aidin refolding the balloon.

FIG. 6 illustrates a side view of a movable protection/rewrapping device600. The movable device 600 may include a tubular member 602 having afirst end 604 and a second end 606. The tubular member 602 may define aninner lumen such as a bore 608 extending between the first end 604 andthe second end 606. The tubular member 602 may be slideable over thecatheter shaft from a position at the proximal end of the catheter shaftto a deflated balloon. The device 600 may then be slid in a distaldirection over the deflated balloon to fold or rewrap the deflatedballoon. The first or proximal end 604 of the tubular member 602 mayhave an outwardly flared end 605. The second or distal end 606 may havea tapered end 603 with a reduced diameter. The inwardly tapered end 603of the tubular member 602 may aid insertion of the balloon and device600 into the hemostasis valve. The outwardly flared end 605 may preventthe device 600 from being inserted completely into the hemostasis valve.

FIG. 7 shows a perspective view of the movable protection/rewrappingdevice 600 of FIG. 6. The device 600 may include the tubular member 602defining the bore 608 having an inner surface. The inner surface may beconfigured to rewrap a deflated balloon. The inner surface may include anumber of ribs 620 extending from the first end 604 to the second end606 similar to the embodiment shown in FIG. 4. In this embodiment, theribs 620 may extend straight along the longitudinal axis between thefirst end 604 and the second end 606.

FIG. 8 shows an end view of the movable protection/rewrapping device 600of FIG. 7 taken from the first end 604. As shown, the tubular member 602may include the bore 608 defining the inner surface. The ribs 620 aredisposed on the inner surface of the bore 608 and extend straight alongthe longitudinal axis. The ribs 620 are positioned to form valleys ofthe balloon folds. In this embodiment, the deflated balloon may befolded into a three wing fold. For example, the balloon may have threeflaps with the valleys formed by the ribs 620 between adjacent flaps.The device may have an inward taper 603 at the second end 606

FIG. 9 shows a perspective view of a movable protection/rewrappingdevice 900 with ribs 920 extending helically along the inner surface ofthe tubular member 902. The device 900 may include a tubular member 902defining a bore 908 having an inner surface. The inner surface mayinclude a plurality of ribs 920 and is configured to protect and rewrapa deflated balloon. As shown, the ribs 920 may extend helically alongthe inner surface between the first end 904 and the second end 906. Insome embodiments, the user may turn or twist either the device 900 orthe catheter shaft to rewrap the balloon. The turning movement may causethe balloon to get wrapped upon the catheter shaft forming folds in thedirection of turning.

A view of the protection/rewrapping device 900 from the flared end 905is shown in FIG. 10. The ribs 920 disposed within the bore 908 along theinner surface of the tubular member 902 may be present along thecircumference in the helical pattern. The device 900 may have aninwardly tapered end 903 which may enable easy insertion into thehemostasis valve.

FIG. 11 shows a perspective view of a movable protection/rewrappingdevice 1100 with ribs 1120 extending helically. The device 1100 mayinclude a tubular member 1102 defining a bore 1108 having an innersurface. The inner surface may include a plurality of ribs 1120 and maybe configured to rewrap a deflated balloon. As shown, the ribs 1120 mayextend helically along the inner surface between a first end 1104 andsecond end 1106 of the tubular member 1102.

In some embodiments, the ribs 1120 can be protrusions integrally e.g.,monolithically formed with the tubular member. However, in someembodiments, the ribs 1120 may be protrusions formed and disposed withinthe bore 1108 of the tubular member 1102. In the illustrated embodiment,each rib 1120 may include a channel 1122 extending lengthwise along therib 1120, as shown in FIGS. 11 and 12. The channel 1122 may beconfigured to guide the deflated balloon into the desired foldingpattern. The channels 1122 may engage flaps in the balloon to furtheraid in a predetermined folding pattern. The ribs 1120 and channels 1122may minimize surface area contact between the inner surface of thedevice 1100 and the deflated balloon.

In some embodiments, a first end 1104 may be tapered or flared outward1105. The second end 1106 may have an inward taper 1103 which may enableinsertion of the balloon and device 1100 into the hemostasis valve. Theflared end 1105 may prevent the device 1100 from completely entering thehemostasis valve.

FIG. 12 shows a view of the device 1100 from the flared end 1105. Asshown, the ribs 1120 may extend helically along the inner surface of thetubular member 1102 and may include protrusions with channels 1122disposed along the inner surface. The bore 1108 may have a circularcross-section and is configured to receive the balloon catheter.

In some embodiments, an axially moveable device 600, 900, 1100 such asthose illustrated in FIGS. 6-12 may be placed onto a catheter shaft 300during manufacture prior to either bonding the balloon 340 or a manifold320 onto the catheter shaft 300. As shown in FIG. 13A, the device 600,900, 1100 may be initially positioned on the catheter shaft 300 justdistal of the strain relief 350. In some embodiments, the strain relief350, the catheter shaft 300, and/or the device 600, 900, 1100 may have alocking mechanism (not shown) configured to retain the device inposition at the proximal end of the catheter shaft until needed.

Another aspect of the disclosure is a method of inserting a ballooncatheter through a hemostasis valve to a treatment site within the bodyusing a device 100, 400. In some examples, the device 100, 400 mayinclude a tubular member 102, 402 having a tapered end 103, 403, a bore108, 408, a longitudinal slit 110, 410, and an actuator 114, 414configured to expand the slit 110, 410 thereby expanding the device.Once open, the device 100, 400 may be applied laterally onto the balloonwith the inwardly tapered end 103, 403 disposed toward the distal end ofthe balloon. The tapered end 103, 403 may be partially inserted into thehemostasis valve to aid in inserting the balloon through the valve. Thedevice 100, 400 allows the user to grasp the balloon without directlycontacting the balloon, thereby protecting the balloon from damageduring insertion of the balloon through the hemostasis valve. Anycoating such as a drug coating, on the balloon, is also protected by thedevice 100, 400. In some examples, the balloon may not have sufficientcolumn strength to be advanced into the valve without damaging theballoon. The device 400 may provide the needed column strength as wellas protecting the balloon from handling by the user. Once the balloon isfully inserted through the hemostasis valve, the device 100, 400 may belaterally removed from the catheter.

In some examples, insertion of the balloon catheter may includewithdrawal of the catheter after inflation and treatment of a firsttreatment site, refolding or rewrapping the deflated balloon, andreinsertion of the catheter for treatment of a second treatment site.Once a treatment procedure is completed at the first treatment site, theballoon may be deflated and retracted proximally from the firsttreatment site and through the hemostasis valve. Some treatmentprocedures involve performing a similar procedure at a second treatmentsite with the same balloon. In these procedures, the balloon is requiredto be rewrapped to pass the balloon into a body lumen or vessel throughthe hemostasis valve. In some procedures the balloon is removedcompletely from the body and is then reinserted to a different location.After having been inflated and then deflated, the balloon may not returnto its initial tightly folded configuration. This may result in damageto the balloon during reinsertion through the hemostasis valve. Thedevice 400, 600, 900, 1100 may aid in refolding or rewrapping theballoon prior to reinsertion, as well as protecting the balloon duringhandling.

In some embodiments, the rewrapping device 400 may include a tubularmember having a bore, one or more ribs disposed within the bore, and alongitudinal slit. Also, the rewrapping device may include an actuatorthat may allow the slit to expand and the rewrapping device to open andbe disposed laterally onto the catheter shaft. Once open, the rewrappingdevice may be applied laterally onto the catheter shaft at a firstposition adjacent a proximal end of the balloon. The rewrapping devicemay then be slid to a second position over the deflated balloon,rewrapping the deflated balloon as the device is moved over the balloon.The device may be twisted or rotated as it is moved over the balloon toaid in rewrapping the balloon.

When properly positioned, the balloon lies within the bore of therewrapping device. In this regard, the size of the tubular member ischosen such that the balloon is entirely covered by the rewrappingdevice. The rewrapping device may be used to insert the balloon throughthe hemostasis valve of the guide sheath. In such a step, a portion ofthe rewrapping device may be inserted into the valve as the catheter isinserted into the guide sheath. Once the catheter is advanced to asuitable depth, the rewrapping device can be removed laterally byopening using the actuator.

In one example, a device 400 having one or more ribs 420 disposed withinthe bore 408 may be used to aid in rewrapping a balloon, in addition toproviding protection to the balloon. The device 400 may be laterallydisposed onto the catheter shaft at a first position adjacent a proximalend of the catheter. The device 400 may then be slid to a secondposition over the deflated balloon, rewrapping the deflated balloon asthe device is moved over the balloon. The ribs 420 may aid in achievingthe desired folded configuration by guiding folds or wings of theballoon. Once the device 400 is disposed over the balloon, the device400 may be used to guide the balloon into the hemostasis valve byinserting the tapered end 403 at least partially into the valve. Thedevice 400 also protects the balloon from damage due to handling. Whenproperly positioned, the balloon lies within the bore of the device. Inthis regard, the size of the tubular member may be chosen such that theballoon is entirely covered by the device.

In another example, an axially moveable device 600, 900, 1100 may beused to aid insertion of the balloon 340 into a hemostasis valve 360 ofa guide sheath. As shown in FIG. 13A, the device 600, 900, 1100 may bemounted on the catheter shaft such that the device may move axiallyalong the catheter shaft 300 between the strain relief 350 and theballoon 340. The device 600, 900, 1100 may then be advanced over theballoon 340. FIG. 13B illustrates the device 600, 900, 1100 disposedover the balloon just proximal of the hemostasis valve 360. The device600, 900, 1100 may provide protection to the balloon as well as providea region for the user to grasp when inserting the balloon into the valve360. In some examples, the balloon may not have sufficient columnstrength to be advanced into the valve 360 without damaging the balloon.The device 600, 900, 1100 may provide the needed column strength as wellas protecting the balloon from handling by the user. In some examples,the balloon may have a drug coating that may also be protected by thedevice 600, 900, 1100. The user may grasp the device 600, 900, 1100 andinsert the distal end thereof partially into the valve 360. An inwardtaper 603, 903, 1103 at the distal end of the device 600, 900, 1100 mayaid in inserting the distal end of the device partially into the valve360. The balloon catheter 300 may then be fully advanced through thevalve 360 into the guide sheath, after which the device 600, 900, 1100is withdrawn proximally and parked near the strain relief 350.

In procedures involving insertion of the balloon catheter to a firsttreatment site, inflation of the balloon, treatment, deflation of theballoon and withdrawal of the catheter, followed by rewrapping theballoon for insertion to a second treatment site, the device 600, 900,1100 may aid in rewrapping the balloon. After withdrawal of the balloonfrom the valve after the first treatment procedure, the device 600, 900,1100 may again be slid from its position near the proximal end of thecatheter, distally onto the balloon. In some examples, one or more ribs620, 920, 1120 on an inner surface of the bore 608, 908, 1108 may aid inrewrapping the balloon into the desired folded configuration. The device600, 900, 1100 may be twisted or rotated as it is advanced onto theballoon to aid in rewrapping the balloon. The device 600, 900, 1100 mayagain be used to aid in inserting the balloon into the hemostasis valve360. Upon fully inserting the balloon through the valve 360, the device600, 900, 1100 is withdrawn proximally and parked near the proximal endof the catheter 300.

The materials that can be used for the various components of the device100, 400, 600, 900, 1100 (and/or other devices disclosed herein) mayinclude those commonly associated with medical devices. For simplicitypurposes, the following discussion makes reference to the device 100.However, this is not intended to limit the devices and methods describedherein, as the discussion may be applied to other similar tubularmembers and/or components of tubular members disclosed herein.

The device 100 and the various components thereof may be made from ametal, metal alloy, polymer (some examples of which are disclosedbelow), a metal-polymer composite, ceramics, combinations thereof, andthe like, or other suitable material. Some examples of suitable polymersmay include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene(ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, forexample, DELRIN® available from DuPont), polyether block ester,polyurethane (for example, Polyurethane 85A), polypropylene (PP),polyvinylchloride (PVC), polyether-ester (for example, ARNITEL®available from DSM Engineering Plastics), ether or ester basedcopolymers (for example, butylene/poly(alkylene ether) phthalate and/orother polyester elastomers such as HYTREL® available from DuPont),polyamide (for example, DURETHAN® available from Bayer or CRISTAMID®available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), Marlex high-density polyethylene, Marlexlow-density polyethylene, linear low density polyethylene (for exampleREXELL®), polyester, polybutylene terephthalate (PBT), polyethyleneterephthalate (PET), polytrimethylene terephthalate, polyethylenenaphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI),polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide(PPO), poly paraphenylene terephthalamide (for example, KEVLAR®),polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMSAmerican Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinylalcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments the sheath can be blendedwith a liquid crystal polymer (LCP). For example, the mixture cancontain up to about 6 percent LCP.

Some examples of suitable metals and metal alloys include stainlesssteel, such as 304V, 304L, and 316LV stainless steel; mild steel;nickel-titanium alloy such as linear-elastic and/or super-elasticnitinol; other nickel alloys such as nickel-chromium-molybdenum alloys(e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY®C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys,and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL®400, NICKELVAC® 400, NICORROS® 400, and the like),nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such asMP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 suchas HASTELLOY® ALLOY B2®), other nickel-chromium alloys, othernickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-ironalloys, other nickel-copper alloys, other nickel-tungsten or tungstenalloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenumalloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like);platinum enriched stainless steel; titanium; combinations thereof; andthe like; or any other suitable material.

As alluded to herein, within the family of commercially availablenickel-titanium or nitinol alloys, is a category designated “linearelastic” or “non-super-elastic” which, although may be similar inchemistry to conventional shape memory and super elastic varieties, mayexhibit distinct and useful mechanical properties. Linear elastic and/ornon-super-elastic nitinol may be distinguished from super elasticnitinol in that the linear elastic and/or non-super-elastic nitinol doesnot display a substantial “superelastic plateau” or “flag region” in itsstress/strain curve like super elastic nitinol does. Instead, in thelinear elastic and/or non-super-elastic nitinol, as recoverable strainincreases, the stress continues to increase in a substantially linear,or a somewhat, but not necessarily entirely linear relationship untilplastic deformation begins or at least in a relationship that is morelinear that the super elastic plateau and/or flag region that may beseen with super elastic nitinol. Thus, for the purposes of thisdisclosure linear elastic and/or non-super-elastic nitinol may also betermed “substantially” linear elastic and/or non-super-elastic nitinol.

In some cases, linear elastic and/or non-super-elastic nitinol may alsobe distinguishable from super elastic nitinol in that linear elasticand/or non-super-elastic nitinol may accept up to about 2-5% strainwhile remaining substantially elastic (e.g., before plasticallydeforming) whereas super elastic nitinol may accept up to about 8%strain before plastically deforming. Both of these materials can bedistinguished from other linear elastic materials such as stainlesssteel (that can also can be distinguished based on its composition),which may accept only about 0.2 to 0.44 percent strain beforeplastically deforming.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy is an alloy that does not show anymartensite/austenite phase changes that are detectable by differentialscanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA)analysis over a large temperature range. For example, in someembodiments, there may be no martensite/austenite phase changesdetectable by DSC and DMTA analysis in the range of about −60 degreesCelsius (° C.) to about 120° C. in the linear elastic and/ornon-super-elastic nickel-titanium alloy. The mechanical bendingproperties of such material may therefore be generally inert to theeffect of temperature over this very broad range of temperature. In someembodiments, the mechanical bending properties of the linear elasticand/or non-super-elastic nickel-titanium alloy at ambient or roomtemperature are substantially the same as the mechanical properties atbody temperature, for example, in that they do not display asuper-elastic plateau and/or flag region. In other words, across a broadtemperature range, the linear elastic and/or non-super-elasticnickel-titanium alloy maintains its linear elastic and/ornon-super-elastic characteristics and/or properties.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy may be in the range of about 50 to about 60 weightpercent nickel, with the remainder being essentially titanium. In someembodiments, the composition is in the range of about 54 to about 57weight percent nickel. One example of a suitable nickel-titanium alloyis FHP-NT alloy commercially available from Furukawa Techno Material Co.of Kanagawa, Japan. Some examples of nickel titanium alloys aredisclosed in U.S. Pat. Nos. 5,238,004 and 6,508,803, which areincorporated herein by reference. Other suitable materials may includeULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available fromToyota). In some other embodiments, a superelastic alloy, for example asuperelastic nitinol can be used to achieve desired properties.

It is to be understood that even though numerous characteristics ofvarious embodiments have been set forth in the foregoing description,together with details of the structure and function of variousembodiments, this detailed description is illustrative only, and changesmay be made in detail, especially in matters of structure andarrangements of parts illustrated by the various embodiments to the fullextent indicated by the broad general meaning of the terms in which theappended claims are expressed. This may include, to the extent that itis appropriate, the use of any of the features of one example embodimentbeing used in other embodiments. The invention's scope is, of course,defined in the language in which the appended claims are expressed.

What is claimed is:
 1. A removable protection device for a ballooncatheter, comprising: a tubular member having a bore extending along alength thereof, wherein the tubular member is flared away from the boreat one end; and at least one rib extending along an inner surface of thebore.
 2. The device of claim 1, comprising three ribs spaced apart andextending substantially straight along the inner surface of the bore. 3.The device of claim 1, comprising three ribs spaced apart and extendingin a helical pattern along the inner surface of the bore.
 4. The deviceof claim 1, wherein the at least one rib includes a protrusion with achannel extending lengthwise along the protrusion.
 5. The device ofclaim 1, wherein the tubular member includes a slit extending along thelength thereof and a hinge region opposite the slit, the tubular memberfurther including an actuator configured to expand the slit, therebyopening the tubular member.
 6. The device of claim 5, wherein theactuator includes first and second spaced apart tabs extending radiallyaway from the tubular member, the first and second tabs configured suchthat movement of the tabs toward each other causes the slit to expand,allowing the device to be placed laterally over a catheter shaft.
 7. Thedevice of claim 1, further comprising a catheter shaft having a proximalend and a distal end, the catheter shaft having a balloon disposed atthe distal end, wherein the tubular member is slidably disposed on thecatheter shaft adjacent the proximal end of the catheter shaft, thetubular member configured to slide along the catheter shaft and over theballoon in a deflated state, thereby rewrapping the deflated balloon. 8.A laterally removable protection and/or rewrapping device for a ballooncatheter, comprising: a tubular member having a first end, a second end,and a bore extending therebetween, the tubular member having a slitextending from the first end to the second end, and a hinge regionopposite the slit, the bore having a shaped inner surface configured torewrap a deflated balloon with two or more folds; and an actuatorconfigured to expand the slit, allowing the tubular member to beinserted laterally over a catheter shaft.
 9. The device of claim 8,wherein the shaped inner surface of the bore includes two or more ribsextending substantially straight along the bore from the first end tothe second end.
 10. The device of claim 8, wherein the shaped innersurface of the bore includes two or more ribs extending in a helicalpattern along the bore.
 11. The device of claim 8, wherein the tubularmember is flared out from the bore at one or both of the first andsecond ends.
 12. A method of rewrapping a deflated balloon, comprising:expanding and then deflating an expandable balloon on a catheter shaft,the catheter shaft having a proximal end and a distal end, wherein theexpandable balloon is disposed on the distal end; moving a rewrappingdevice distally over the catheter shaft and onto the balloon, therebyrewrapping the balloon, the rewrapping device including a tubular memberhaving a bore extending along a length thereof, and at least one ribextending along an inner surface of the bore.
 13. The method of claim12, wherein the rewrapping device includes three ribs spaced apart andextending substantially straight along the inner surface of the bore.14. The method of claim 12, wherein the rewrapping device includes threeribs spaced apart and extending in a helical pattern along the innersurface of the bore.
 15. The method of claim 12, wherein the rewrappingdevice is slidably disposed on the catheter shaft, wherein moving therewrapping device includes sliding the rewrapping device from a firstposition adjacent the proximal end of the catheter to a second positiondisposed over the balloon.
 16. The method of claim 15, wherein slidingthe rewrapping device to the second position disposed over the balloonincludes rotating the rewrapping device onto the balloon.
 17. The methodof claim 12, wherein the tubular member includes a slit extending alongthe length thereof and a hinge region opposite the slit, the tubularmember further including an actuator configured to expand the slit,wherein moving the rewrapping device includes actuating the tubularmember to expand the slit, laterally moving the rewrapping device ontothe catheter shaft proximal of the balloon, and sliding the rewrappingdevice over the balloon.
 18. The method of claim 17, wherein theactuator includes first and second spaced apart tabs extending radiallyaway from the tubular member, the first and second tabs configured suchthat movement of the tabs toward each other causes the slit to expand,wherein laterally moving the rewrapping device includes moving the firstand second tabs toward each other to expand the slit, and then placingthe rewrapping device laterally over the catheter shaft.
 19. The methodof claim 12, wherein the inner surface of the tubular member isconfigured to protect the balloon when the tubular member is disposedover the balloon.
 20. The method of claim 12, wherein expanding and thendeflating an expandable balloon includes: inflating the balloon andperforming a treatment procedure at a first treatment site within apatient; deflating the balloon and withdrawing the balloon proximally toa position outside the patient; moving the rewrapping device onto theballoon thereby rewrapping the balloon; and moving the catheter shaftand balloon back into the patient to a second treatment site.